510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203035Substantially Equivalent

Eonis SCID-SMA kit

Revvity Health Sciences, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203035 is the FDA 510(k) clearance record for Eonis SCID-SMA kit, a class II device, cleared for Perkinelmer, Inc. on under FDA product code PJI (Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System). FDA's definition for product code PJI reads: "A newborn screening test for severe combined immunodeficiency (SCID) intended for the detection of T-cell receptor excision circle (TREC) genomic DNA isolated from newborn blood specimens dried on filter paper. It is intended as an aid in...". FDA records list 81 510(k) clearances for Revvity Health Sciences, Inc., from to . As of , FDA records show no recalls naming K203035.

Clearance record

Decision date
Received
(765 days to decision)
Product code
PJI Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
Regulation
21 CFR 866.5930
Device class
Class II
Review panel
Immunology
Applicant
Perkinelmer, Inc. 940 Winter St., Waltham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PJI

Trailing 12 months

FDA records hold no clearances under product code PJI in the trailing twelve months.

FDA records show no clearances under product code PJI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PJI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260